Careers

Come join our diverse team of experts sharing mutual passion and dedication to addressing unmet needs in progressive multiple sclerosis and ALS.

We are running clinical trials across several indications, domestic and internationally. We are seeking a talented and passionate individual that would thrive in a dynamic, fast- paced, team-oriented environment. The Clinical Trial Director will work closely with the Medical Director, Regulatory, and Scientists. The Clinical Trial Director will independently oversee clinical studies from concept to final close and must be a proactive problem-solver with the ability to critically evaluate and manage budget, timelines and key deliverables. Set up of trial sites, local submissions, database oversight, site communications – “making sure the right things are being done and that things are done right.” 

Job Requirements

NeuroGenesis (www.neurogenesis-cell.com) is a cell therapy company focusing on developing a unique subpopulation of bone marrow cells that are selected and enhanced to become remyelinating bio-factory cells (NG-01). The platform technology is optimized for treating central nervous system diseases such as multiple sclerosis (MS) and amyotrophic lateral sclerosis (ALS). The NG-01 technology entails collecting of bone marrow from the patient, then by using a proprietary process, identify and enhance a unique subpopulation of bone marrow cells with outstanding nerve therapeutic properties. NG-01 cells are expanded to tens of millions and injected directly into the spinal cord fluid, home-in on the damaged area, take up residence for up to three months and produce sustained, massive amounts of remyelinating proteins to in-situ remyelinate and repair. NeuroGenesis’ initial focus is on progressive MS. To date, more than 140 patients have been treated with NG-01 via an open label study (Published in Jama Neurology), long term studies (4 years, Frontiers of Neurology), a placebo-controlled trial (Brain, Editor’s Choice) as well as compassionate treatments. Neurogenesis is looking for a cell therapy leader with GMP manufacturing expertise to serve as Director of Manufacturing. This is an exciting opportunity to join Neurogenesis and be part of building the company’s cell therapy manufacturing strategy. The ideal candidate will have expertise in cell therapy manufacturing with a demonstrated track record of successful development-to-clinical product transitions.

Job Requirements

job requirements

Clinical Trial Director

Job Responsibilities:

Assess internal and external scientific data to better adapt trial designs and interpret trial results

  • Understand and present clinical trial results
  • Selecting and managing contract research organizations and other outside vendors to support clinical studies
  • Independently manage study activities, including selection of investigators, study start-up activities, study monitoring    activities and data collection
  • Developing and managing study timelines
  • Assisting in the development of study related documents (ICFs, protocols, IBs)

Candidate Requirements:

  • BA/BS and five or more years experience of direct clinical trial management, including management of vendors and CROs
  • Experience in degenerative neurological disease clinical development is preferred, US and EU experience a plus
  • Experience as a monitor is strongly preferred
  • Experience in Phase I – II clinical trials (Phase III preferred)
  • Working knowledge of GCP and ICH is required
  • Effective communication (English – written and verbal), adaptability and self-motivation are required attributes
  • Approximately 20% travel, primarily involving trips to Investigator sites, Investigator meetings or co-monitoring
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job requirements

Director of Manufacturing in Cell Therapy

Key Responsibilities:

The primary accountability of this role is to enable the manufacturing of cell therapy
products for clinical supply, as a cell therapy technical expert for cGMP manufacturing, through providing hands-on technical leadership and operational oversight for a cell therapy manufacturing facility in Rochester, NY.
We are looking for a candidate with excellent GMP, scientific, technical communication, and leadership skills.

Specifically: 

  • Provide leadership to establish the operation of a GMP cell therapy manufacturing facility from scratch
  • Hire & manage operational staff, including developing staff capabilities through initial and ongoing training and maintaining team compliance
  • Provide management oversight of international tech transfer activities
  • Manage the production schedule and the daily tasks of the Manufacturing Operators
  • Provide oversight and guidance related to training materials, SOPs, batch records, reports, risk assessments, materials management, etc
  • Work cross-functionally with process development, quality, and other counterparts for the development of next-generation cGMP cell therapy manufacturing processes
  • Works closely with senior management to initiate new projects and assist in developing processes/techniques to meet business objectives

Basic Qualifications:

  •  Master’s degree in life science or engineering with a minimum of 5 years of industry experience.
  •  2 years in managing direct reports or project teams
  •  2 years of experience in cell therapy
  •  Experience in GMP documentation and compliance
  •  Ability to operate and thrive in a fast-paced, high-growth environment.
  •  Problem solving and can-do approach
  •  Excellent communication skills

Preferred Qualifications:

  •  MSc in cell biology or biotechnology
  •  Specific experience in cell GMP manufacturing facilities with expertise in cell therapy
  •  Involvement in delivering a cell therapy-based product into clinical development
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